ClearWay™ RX Registry Trial

Completed

• Conditions: Vascular Diseases; Heart Diseases
• Interventions: Device: ClearWay™ RX Local Therapeutic Infusion Catheter

• Registration Number: NCT00804024
• Lead Sponsor: Atrium Medical Corporation

Brief Summary

The primary goal of this registry is to collect data regarding the use of the ClearWay RX Local Therapeutic Infusion Catheter for all indications.

Detailed Description

The registry will collect de-identified data regarding the indication for use, ease of use, drug perfusion, catheterization procedure details, success for intended use, and overall operator performance evaluation.

Study Timeline

• Study Start: 2008-08
• Study First Submitted: 2008-12-05
• Study First Submitted QC: 2008-12-05
• Study First Posted: 2008-12-08
• Primary Completion: 2010-10
• Study Completion: 2010-10
• Status Verified: 2013-04
• Last Update Submitted: 2013-04-18
• Last Update Posted: 2013-04-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 102

Inclusion Criteria

• Subject required the use of the ClearWay Rx Local Therapeutic Infusion Catheter.

Exclusion Criteria

• Subject not meeting the above inclusion criterion

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
ClearWay™ RX	ClearWay™ RX Local Therapeutic Infusion Catheter	-

Primary Outcome Measures

Name	Time	Method
use, easy of use, drug perfusion, catheterization procedure details, success for intended use, and overall operator performance evaluation.	immediate

Trial Locations

Locations (13)

Escondido Cardiology Associates; 🇺🇸 Escondido, California, United States

The Georgia Heart Center; 🇺🇸 Macon, Georgia, United States

Western Baptist Hospital; 🇺🇸 Paducah, Kentucky, United States

Winter Haven Florida; 🇺🇸 Winter Haven, Florida, United States

Washington Hospital Center; 🇺🇸 Washington, District of Columbia, United States

Genesys Regional Medical Center; 🇺🇸 Grand Blanc, Michigan, United States

Clarian Health Partners Methodist Research Institute; 🇺🇸 Indianapolis, Indiana, United States

Great Lakes Heart & Vascular Institute; 🇺🇸 St.Joseph, Michigan, United States

St.Mary's Duluth Clinic Health System; 🇺🇸 Duluth, Minnesota, United States

Presbyterian Hospital Mid-Carolina Cardiology; 🇺🇸 Charlotte, North Carolina, United States

Forsyth Medical Center-Cardiovascular Research; 🇺🇸 Winston-Salem, North Carolina, United States

Good Samaritan Hospital; 🇺🇸 Lebanon, Pennsylvania, United States

Virginia Cardiovascular Specialists; 🇺🇸 Richmond, Virginia, United States